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Drug Interactions between Protropin and vamorolone

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

somatrem vamorolone

Applies to: Protropin (somatrem) and vamorolone

Consumer information for this interaction is not currently available.

MONITOR: Human growth hormone may reduce the pharmacologic effects of corticosteroids. Growth hormone is thought to enhance the activity of CYP450 3A4, an enzyme involved in the catabolism of corticosteroids. In addition, growth hormone (GH) inhibits microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11BHSD-1), which is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. Consequently, individuals with untreated GH deficiency have relative increases in 11BHSD-1 and serum cortisol, and initiation of GH therapy may result in inhibition of 11BHSD-1 and reduced serum cortisol levels. Previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required. In patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism, an increase in their maintenance or stress doses may be required following initiation of GH treatment. Cortisone acetate and prednisone may be affected more than others because conversion to their biologically active metabolites, cortisol and prednisolone, respectively, is dependent on the activity of 11BHSD-1.

MONITOR: Treatment with pharmacologic and supraphysiologic glucocorticoid dosages may attenuate the growth promoting effects of human growth hormone in children due to inhibition of the hypothalamic-pituitary-adrenal axis.

MANAGEMENT: Higher dosages of corticosteroids may be required during concomitant use of human growth hormone. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of GH treatment. In addition, glucocorticoid replacement dosing should be carefully adjusted in children receiving concomitant GH treatment to avoid both hypoadrenalism and an inhibitory effect on growth.

References

  1. "Product Information. Nutropin (somatropin)." Genentech PROD (2001):
  2. "Product Information. Protropin (somatrem)." Genentech PROD (2001):
  3. "Product Information. Norditropin Cartridge (somatropin)." Novo Nordisk Pharmaceuticals Inc (2004):
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. Cerner Multum, Inc. "Australian Product Information." O 0
View all 5 references

Drug and food interactions

Moderate

vamorolone food

Applies to: vamorolone

Consumer information for this interaction is not currently available.

GENERALLY AVOID: Grapefruit juice may increase the plasma concentrations of vamorolone. The proposed mechanism is inhibition of CYP450 3A4-mediated metabolism in the gut wall by certain compounds present in grapefruit. The metabolism of vamorolone is mediated by the isoenzymes CYP450 3A4/5, and CYP450 2C8, and uridine diphosphate glucuronosyltransferases (UGT) 1A3, 2B7, and 2B17. In general, the effect of grapefruit juice is concentration-, dose-, and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Increased systemic exposure to vamorolone may increase the risk of corticosteroid adverse effects such as hypercorticism, hyperglycemia, adrenal suppression, immunosuppression, hypertension, salt and water retention, electrolyte abnormalities, behavioral and mood disturbances, posterior subcapsular cataracts, glaucoma, bone loss, and growth retardation in children and adolescents.

MANAGEMENT: Until further information is available, it may be advisable for patients to avoid the consumption of large amounts of grapefruit and grapefruit juice during vamorolone therapy unless otherwise directed by their doctor, as the interaction is unreliable and subject to a high degree of interpatient variation. If coadministration is considered necessary, patients should be closely monitored for signs and symptoms of corticosteroid adverse effects. Patients should also be monitored for signs and symptoms of hypercorticism such as acne, striae, thinning of the skin, easy bruising, moon facies, dorsocervical "buffalo" hump, truncal obesity, increased appetite, acute weight gain, edema, hypertension, hirsutism, hyperhidrosis, proximal muscle wasting and weakness, glucose intolerance, exacerbation of preexisting diabetes, and depression. Signs and symptoms of adrenal insufficiency include anorexia, hypoglycemia, nausea, vomiting, weight loss, muscle wasting, fatigue, weakness, dizziness, postural hypotension, depression, and adrenal crisis manifested as an inability to respond to stress (e.g., illness, infection, surgery, trauma). Consultation with product labeling for specific recommendations is advisable.

References

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  5. Glynn AM, Slaughter RL, Brass C, et al. "Effects of ketoconazole on methylprednisolone pharmacokinetics and cortisol secretion." Clin Pharmacol Ther 39 (1986): 654-9
  6. Itkin IH, Menzel ML "The use of macrolide antibiotic substances in the treatment of asthma." J Allergy Clin Immunol 45 (1970): 146-62
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  8. Finkenbine RD, Frye MD "Case of psychosis due to prednisone-clarithromycin interaction." Gen Hosp Psychiat 20 (1998): 325-6
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  10. Hillebrand-Haverkort ME, Prummel MF, ten Veen JH "Ritonavir-induced Cushing's syndrome in a patient treated with nasal fluticasone." AIDS 13 (1999): 1803
  11. Varis T, Kivisto KT, Neuvonen PJ "The effect of itraconazole on the pharmacokinetics and pharmacodynamics of oral prednisolone." Eur J Clin Pharmacol 56 (2000): 57-60
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  14. Lebrun-Vignes B, Archer VC, Diquest B, et al. "Effect of itraconazole on the pharmacokinetics of prednisolone and methylprednisolone and cortisol secretion in healthy subjects." Br J Clin Pharmacol 51 (2001): 443-50
  15. Couturier J, Steele M, Hussey L, Pawliuk G "Steroid-induced mania in an adolescent: risk factors and management." Can J Clin Pharmacol 8 (2001): 109-12
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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

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